FORM
6-K
SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C.
20549
Report
of Foreign Issuer
Pursuant to Rule
13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of March 2022
Commission File
Number: 001-11960
AstraZeneca
PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge CB2
0AA
United
Kingdom
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AstraZeneca
PLC
INDEX
TO EXHIBITS
1.
Evusheld Positive EU CHMP Opinion
24
March 2022 18:00 GMT
Evusheld long-acting
antibody combination recommended for approval
in the EU for the pre-exposure prophylaxis (prevention) of
COVID-19
Recommendation based on Phase III PROVENT trial
showing
a significant reduction in the risk of developing symptomatic
COVID-19,
with protection lasting at least six months
AstraZeneca's Evusheld (tixagevimab co-packaged with cilgavimab), a
long-acting antibody combination, has been recommended for
marketing authorisation in the European Union (EU) for the
pre-exposure prophylaxis (prevention) of COVID-19 in a broad
population of adults and adolescents aged 12 years and older
weighing at least 40 kg.
People not adequately protected by a COVID-19
vaccine may particularly benefit from pre-exposure prophylaxis
with Evusheld. This includes about three million people in the
EU who are immunocompromised or being treated with
immunosuppressive medicines.1
The Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency based its positive opinion
on a review of Evusheld data, including results from the PROVENT
Phase III pre-exposure prophylaxis trial, which showed a 77%
reduction in the risk of developing symptomatic COVID-19 compared
to placebo at the primary analysis and an 83% reduction at a six
month median analysis, with protection from the virus continuing
for at least six months.2-4 Evusheld was
generally well-tolerated in the trial.2-4
Hugh Montgomery,
Professor of Intensive Care Medicine at University College London,
UK and Evusheld investigator
said: "Despite the success
of vaccinations, we still need additional measures to prevent the
spread of COVID-19 infections in Europe, where the number of cases
of the highly transmissible BA.2 subvariant is rapidly increasing
and where public health safety measures have been relaxed in many
countries. This broad recommendation for Evusheld will allow health authorities in the EU to
identify priority, high-risk populations needing additional
protection such as people with cancer, transplant patients, or
anyone taking immunosuppressive medicines, as well as those at
increased risk of exposure."
Mene Pangalos, Executive Vice President,
BioPharmaceuticals R&D, AstraZeneca, said: "Today's positive
CHMP recommendation represents a significant step forward in our
ongoing efforts to introduce additional, important preventative
measures for people in Europe at higher risk of developing
COVID-19. Evusheld has the potential to provide long-lasting
protection to vulnerable populations such as the immunocompromised
who can't mount an adequate response to a COVID-19 vaccine, and
we'll continue to work with governments in Europe to
make Evusheld available as quickly as
possible."
The recommended dose of Evusheld in Europe is 150mg of tixagevimab and 150mg
of cilgavimab, administered as two separate sequential
intramuscular (IM) injections.
There is a growing body of evidence from multiple
independent in vitro and in vivo (animal model) studies supporting
the potential of Evusheld to protect against the BA.1, BA.1.1 and BA.2
Omicron SARS-CoV-2 subvariants in circulation around the
world.5-7 New data from
Washington University School of Medicine
demonstrated Evusheld retained potent neutralising activity
against the emerging and highly transmissible BA.2 subvariant,
which is the dominant strain in many European countries and
currently accounts for nearly 60% of COVID-19 infections in
Europe.7,8 This
study also showed Evusheld reduced viral burden and limited
inflammation in the lungs (in vivo) across all Omicron
variants.7
Evusheld is authorised for emergency use for
pre-exposure prophylaxis of COVID-19 in the US and in six countries
in Europe. Evusheld has also been granted conditional marketing
authorisation by the Medicines and Healthcare products Regulatory
Agency (MHRA) in Great Britain for pre-exposure prophylaxis of
COVID-19.
AstraZeneca
anticipates that the European Commission will shortly complete its
review of the CHMP positive opinion to determine whether to grant
marketing authorisation.
Evusheld is the only long-acting antibody combination
with positive Phase III data in the prevention and treatment of
COVID-19.3,9 AstraZeneca
is progressing with filings around the globe for potential
emergency use authorisation or marketing approval
of Evusheld in both COVID-19 prophylaxis and
treatment.
Notes
Evusheld
Evusheld, formerly known as AZD7442, is a combination of
two long-acting antibodies - tixagevimab (AZD8895) and
cilgavimab (AZD1061) - derived from B-cells donated by convalescent
patients after SARS-CoV-2 infection. Discovered by Vanderbilt
University Medical Center and licensed to
AstraZeneca in June 2020, the
human monoclonal antibodies bind to distinct sites on the
SARS-CoV-2 spike protein10 and
were optimised by AstraZeneca with half-life extension and
reduction of Fc effector function. The half-life extension more
than triples the durability of its action compared to conventional
antibodies;11-13 data
from the PROVENT Phase III trial show protection lasting at least
six months.14 The
reduced Fc effector function aims to minimise the risk of
antibody-dependent enhancement of disease - a phenomenon in which
virus-specific antibodies promote, rather than inhibit, infection
and/or disease.15
Evusheld received Emergency Use Authorisation (EUA)
in the US in December 2021 for the pre-exposure prophylaxis
(prevention) of COVID-19 in people with moderate to severe immune
compromise due to a medical condition or immunosuppressive
medications and who may not mount an adequate immune response to
COVID-19 vaccination, as well as those individuals for whom
COVID-19 vaccination is not recommended due to a history of severe
adverse reaction to a COVID-19 vaccine. Evusheld is also authorised for use and being
supplied in several other countries around the
world.
The primary data supporting
the Evusheld EUA are from the
ongoing PROVENT Phase III
pre-exposure prevention trial, which showed a statistically significant
reduction (77% at primary analysis, 83% at median six month
analysis) in the risk of developing symptomatic COVID-19 compared
to placebo, with protection from the virus continuing for at least
six months. Follow-up is ongoing to establish the full duration of
protection provided by Evusheld.
In October 2021, AstraZeneca announced positive
high-level results from the TACKLE Phase III
outpatient treatment trial in which a 600mg IM dose
of Evusheld was generally well-tolerated. AstraZeneca is
discussing the TACKLE mild-to-moderate COVID-19 treatment data with
health authorities.
Evusheld was well-tolerated in the
trials.
Evusheld is being developed with support from the US
government, including federal funds from the Department of Health
and Human Services; Office of the Assistant Secretary for
Preparedness and Response; Biomedical Advanced Research and
Development Authority in partnership with the Department of
Defense; Joint Program Executive Office for Chemical, Biological,
Radiological and Nuclear Defense, under Contract No.
W911QY-21-9-0001.
Under
the terms of the licensing agreement with Vanderbilt, AstraZeneca
will pay single-digit royalties on future net sales.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global,
science-led biopharmaceutical company that focuses on the
discovery, development, and commercialisation of prescription
medicines in Oncology, Rare Diseases, and BioPharmaceuticals,
including Cardiovascular, Renal & Metabolism, and Respiratory
& Immunology. Based in Cambridge, UK, AstraZeneca operates in
over 100 countries and its innovative medicines are used by
millions of patients worldwide. Please
visit astrazeneca.com and
follow the Company on Twitter @AstraZeneca.
Contacts
For details on how to contact the Investor
Relations Team, please click here.
For Media contacts, click here.
References
1.
AstraZeneca Data on File.
2. US Food and Drug
Administration. FACT SHEET FOR HEALTHCARE PROVIDERS: EMERGENCY USE
AUTHORIZATION FOR EVUSHELDTM (tixagevimab co-packaged with
cilgavimab). Available at: https://www.fda.gov/media/154701/download [Last
accessed March 2022].
3. AstraZeneca news
release. AZD7442 PROVENT Phase III prophylaxis trial met primary
endpoint in preventing COVID-19. Available
at: https://www.astrazeneca.com/media-centre/press-releases/2021/azd7442-prophylaxis-trial-met-primary-endpoint.html [Last
accessed: March 2022].
4. AstraZeneca news
release. New analyses of two AZD7442 COVID-19 trials in high-risk
populations confirm robust efficacy and long-term prevention.
Available at: https://www.astrazeneca.com/media-centre/press-releases/2021/new-analyses-of-two-azd7442-covid-19-phase-iii-trials-in-high-risk-populations-confirm-robust-efficacy-and-long-term-prevention.html.
[Last accessed: March 2022]
5. Dejnirattisai W, et
al. SARS-CoV-2 Omicron-B.1.1.529 leads to widespread escape
from neutralizing antibody responses. Cell. 2022;185(3):467-484.e15.
6. VanBlargan LA, et al. An
infectious SARS-CoV-2 B.1.1.529 Omicron virus escapes
neutralization by therapeutic monoclonal
antibodies. Nature
Medicine. 2022.
28:490-495.
7. Case, J et
al. Resilience of S309 and AZD7442 monoclonal antibody treatments
against infection by SARS-CoV-2 Omicron lineage strains. Available
at: https://www.biorxiv.org/content/10.1101/2022.03.17.484787v1 [Last
accessed March 2022].
8. COVID CG. (2022). GISAID.
Available
at: https://covidcg.org/?groupKey=lineage®ion=Europe&residueCoordinates=1%2C1274&selectedGene=S&tab=group [Last
accessed: March 2022].
9. AstraZeneca
news release. Evusheld reduced
risk of developing severe COVID-19 or death in TACKLE Phase III
outpatient treatment trial. Available at: https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/Evusheld-phiii-trial-positive-in-covid-outpatients.html.
[Last accessed: March 2022].
10. Dong J, et al. Genetic and structural
basis for recognition of SARS-CoV-2 spike protein by a two-antibody
cocktail. bioRxiv. 2021; doi:
10.1101/2021.01.27.428529.
11. Robbie GJ, et al. A novel
investigational Fc-modified humanized monoclonal antibody,
motavizumab-YTE, has an extended half-life in healthy
adults. Antimicrob Agents
Chemother. 2013; 57 (12):
6147-53.
12. Griffin MP, et al. Safety, tolerability,
and pharmacokinetics of MEDI8897, the respiratory syncytial virus
prefusion F-targeting monoclonal antibody with an extended
half-life, in healthy adults. Antimicrob Agents
Chemother. 2017; 61(3):
e01714-16.
13. Domachowske JB, et al. Safety,
tolerability and pharmacokinetics of MEDI8897, an extended
half-life single-dose respiratory syncytial virus prefusion
F-targeting monoclonal antibody administered as a single dose to
healthy preterm infants. Pediatr Infect Dis
J. 2018; 37(9):
886-892.
14. van Erp EA, et al. Fc-mediated
antibody effector functions during respiratory syncytial virus
infection and disease. Front
Immunol. 2019; 10:
548.
Adrian Kemp
Company Secretary
AstraZeneca PLC
SIGNATURES
Pursuant to the
requirements of the Securities Exchange Act of 1934, the Registrant
has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
Date:
24 March 2022
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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